New Prospective Expanded German Registry of Incidental Gallbladder Carcinoma (PERSUASION)- a Permanent Platform Including All Kind of Biliary Tract Cancers (BTC)
- Conditions
- Biliary Tract CancerNeoadjuvant, Adjuvant and 1st Line
- Registration Number
- NCT04896931
- Lead Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Brief Summary
Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers.
- Detailed Description
Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL for all types of biliary tract cancers. The registry does not define any medical intervention and does not evaluate the efficacy or safety of the treatment decision made by the investigator. Every adverse event whether related to a treatment or not, will neither be documented in the trial´s eCRF nor be reported to the leading investigators of this study.
Objectives: • To establish a registry with a representative BTC-patient population in German-speaking Europe (mainly DACH region) for current and future research. The study registry is not based on a primary endpoint. The data collection includes (among basic patient-/tumor-/treatment- characteristics) the survey of quality of life (EORTC-C30), a so-called patient-reported outcome (PRO) and - if available - the collection of tissue samples for translational accompanying projects.
* Clinical data:
* To analyse potential risk factors associated with BTC-cancer addressing clinical and biological predictors of treatment success and survival
* To determine the course of disease and QoL throughout all applied therapy lines for patients with BTC
* To measure progression-free, disease-free and overall survival in different BTC sub-groups, mortality and morbidity for perioperative and palliative therapy procedures
* Recording of the therapy regimens and therapy sequences used across all treatment lines
* Molecular data (Data- and Biobanking):
* To establish a sample collection for future molecular/genetic biomarker characterization to enable for e.g. assessment of the frequency of targetable mutations and associated therapy decisions or progression analysis in baseline and follow-up investigations
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Known biliary-tract cancer including intrahepatic-, extrahepatic- and gallbladder carcinomas
- age ≥18 years
- signed informed consent form
- planned for (or recently started - i.e. within the last 21 days)) neoadjuvant, adjuvant or 1st line therapy
- Patients who are unable to consent because they do not understand the nature, significance and implications of the registry and therefore cannot form a rational intention
- Patient under 18 years of age
- Patient's inability to complete QoL questionnaire or answer the questions.
- Second-line or further palliative therapies if the patient's first-line therapy was not documented within the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Establishment of BTC population Through study completion, an average of 2 years To establish a representative BTC-patient population in German-speaking Europe in an agile platform study design for future research
- Secondary Outcome Measures
Name Time Method The course of Quality of Life (QoL) throughout the entire course of therapy for patients with BTC Through study completion, an average of 2 years EORTC-QLQC30 according to EORTC scoring manual
mortality Through study completion, an average of 2 years mortality for perioperative and palliative therapy procedures
analyse potential risk factors associated with BTC-cancer Through study completion, an average of 2 years Correlate medical history with patient outcome, find prevalent medical history associated with BTC chancer
DFS Through study completion, an average of 2 years disease-free survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
OS Through study completion, an average of 2 years overall survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
morbidity Through study completion, an average of 2 years morbidity for perioperative and palliative therapy procedures
PFS Through study completion, an average of 2 years progression-free survival in different BTC subgroups and therapy lines. As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
establishment of sample collection (tumorblocks and blood) Through study completion, an average of 2 years establish a sample collection for future molecular/genetic biomarker characterization
Trial Locations
- Locations (25)
Universitätsklinikum Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
Medius Klinik Ostfildern-Ruit
🇩🇪Ostfildern, Baden-Württemberg, Germany
Klinikum St. Marien Amberg
🇩🇪Amberg, Bayern, Germany
Helios Amper-Klinikum Dachau
🇩🇪Dachau, Bayern, Germany
Donau-Isar-Klinikum Deggendorf
🇩🇪Deggendorf, Bayern, Germany
ÜBAG-Medizinisches Versorgungszentrum. Dr. Vehling-Kaiser GmbH
🇩🇪Landshut, Bayern, Germany
LMU Klinikum Campus Großhadern
🇩🇪München, Bayern, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Bayern, Germany
HELIOS Klinikum Bad Saarow
🇩🇪Bad Saarow, Brandenburg, Germany
Ambulantes Zentrum für Hämatologie und Onkologie
🇩🇪Cottbus, Brandenburg, Germany
Universitätsklinikum Gießen
🇩🇪Gießen, Hessen, Germany
Klinikum Südstadt Rostock
🇩🇪Rostock, Mecklenburg-Vorpommern, Germany
St. Bernward Krankenhaus Hildesheim
🇩🇪Hildesheim, Niedersachsen, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Niedersachsen, Germany
Krankenhaus Maria-Hilf Krefeld
🇩🇪Krefeld, Nordrhein-Westfalen, Germany
Klinikum Lippe Lemgo
🇩🇪Lemgo, Nordrhein-Westfalen, Germany
Onkologische Schwerpunktpraxis Speyer
🇩🇪Speyer, Rheinland-Pfalz, Germany
Onkozentrum Dresden
🇩🇪Dresden, Sachsen, Germany
Onkologische Schwerpunktpraxis Freital
🇩🇪Freital, Sachsen, Germany
Universitäres Krebszentrum Universitätsklinikum Leipzig (UCCL)
🇩🇪Leipzig, Sachsen, Germany
Onkologische Schwerpunktpraxis
🇩🇪Naunhof, Sachsen, Germany
Elblandklinikum Riesa
🇩🇪Riesa, Sachsen, Germany
Gemeinschaftspraxis für Onkologie und Hämatologie
🇩🇪Erfurt, Thüringen, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Krankenhaus Nordwest GmbH
🇩🇪Frankfurt, Germany